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A Phase I Study to Find the Best Dose of Arsenic Trioxide to Give by Mouth for Blood Cancers

Full Title

A Phase I, Two-part Study to Determine the Recommended Dose and Evaluate the Safety and Tolerability of a Novel Oral Arsenic Trioxide Formulation (ORH 2014) in Subjects with Advanced Hematological Disorders


Arsenic trioxide is a medication that has been given intravenously to treat patients with acute promyelocytic leukemia (APL). In this study, researchers are finding the best dose of a pill form of arsenic trioxide (called ORH-2014) to give to patients with blood cancers that have come back or continued to grow despite treatment and cannot be cured with other therapies, including: recurrent or persistent APL, acute myeloid leukemia (AML) with NPM-1 mutations, intermediate- or high-risk myelodysplastic syndromes (MDS), mantle cell lymphoma (MCL), and chronic myelomonocytic leukemia (CMML) and other myeloproliferative cancers.


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or persistent APL, AML with NPM-1 mutations, intermediate- or high-risk MDS, MCL, CMML, or other myeloproliferative cancer that cannot be successfully treated with other therapies.
  • Patients must recover from the serious side effects of previous treatments before entering the study.
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.
  • This study is for patients age 19 and older.

For more information about this study and to inquire about eligibility, contact Dr. Martin Tallman at 212-639-3849.





Disease Status

Relapsed or Refractory